Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00253045
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2005-11-14
Brief Title:
Motivating HIV Women Risk Reduction and ART Adherence
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Motivating HIV Women Risk Reduction and ART Adherence
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KHARMA
Brief Summary:
The purpose of this study is to determine if a group motivational interviewing based intervention will increase adherence to antiretroviral medications and use of risk reduction behaviors
Detailed Description:
Women are the fastest growing group of persons with AIDS They are often diagnosed later in the disease when antiretroviral therapy ART is strongly indicated Currently ART involves the use of multiple medications that must be taken under strict conditions at regular time intervals up to as many as 4 different times a day Some medications must be taken on an empty stomach some with high fat food some with low fat food and all of these must be coordinated throughout the day It is extremely important for patients to take ART exactly as prescribed and not miss any doses in order to reduce the amount of HIV virus in the bloodstream increase the CD4 cell counts prevent the serious consequences of AIDS hospitalizations and development of drug resistant strains These regimen-related problems and the high care-taking burden placed on HIV women for their children and partners make near perfect adherence difficult to achieve And as women on ART begin to feel better and resume their normal activities including sexual activities adherence to behaviors that contribute to reducing the risk of spreading HIV RRB such as condom use and safe needle use in injection drug users becomes crucial Researches have shown that only about 11 to 63 of HIV women use condoms consistently
The primary purpose of this randomized controlled behavioral trial is to test the effect of a nurse led group motivational intervention for HIV women on adherence to ART and RRB The secondary purpose is to examine the mediator effect of 3 variables that have been shown to be important in behavior change self-efficacy outcome expectancy and personal goals The Motivational Group Usual Care MGUC intervention builds on the usual care provided at the agencies and has Motivational Interviewing MI as a central component It consists of 8 90 minute sessions 1 week apart led by a specially trained nurse to motivate women to adhere to both ART and RRB The intervention will be compared to an 8 session health promotion program HPPUC that is led by a nurse health educator These sessions will focus on nutrition exercise stress management and womens health issues These sessions will also be 90 minutes in length and meet weekly for 8 weeks Both groups will receive beauty and pampering incentives such as beauty makeovers skin care instruction and massages after several of the sessions as well as child care transportation tokens and monetary incentives of 10 for attendance at each of the first 4 groups and 15 for attendance at each of the last 4 groups Snacks appropriate for ART and immune status will be supplied to the MGUC group and fruits vegetables and other nutritious snacks will be provided to the HPPUC group Groups will be held at AID Atlanta the Infectious Disease Program of the Grady Health System and at the Infectious Disease Clinic of Emory Crawford Long
In order to be eligible to participate the women must be HIV over 18 years of age be on a new or different ART or have self-reported nonadherence to her current ART regimen speak and understand English and be mentally stable as determined by a screening assessment All participants will complete a baseline assessment and follow-up assessments immediately 3 6 and 9 months after the end of the group Participants will be paid 25 for each assessment We expect 300 women to be randomized and participate pregnant women will not be excluded
We hypothesize that the women who are randomized to the MGUC group will on the immediate 3 6 and 9 month follow-up assessments have higher mean adherence rates to ART report more frequent use of RRB have higher CD4 counts and lower mean viral loads than those randomized to the HPPUC group We also hypothesize that the effects of the intervention on adherence to ART and RRB will be brought about by higher mean levels of self-efficacy more positive expected outcomes and more specific and effective personal goals
As noted above MI forms the basis for the intervention MI is a client-focused method of counseling used to help clients deal with ambivalence about changing behavior MI principles include expressing empathy developing discrepancy rolling resistance and supporting self-efficacy It has been used primarily with individuals but some MI groups have been described with substance users Our application in a group format with HIV women is new and innovative
All participants will receive the usual care plus either the Health Promotion Program or the Motivational Interviewing Intervention How the usual care is administered varies by agency but in general for ART consists of prescription of new or different ART regimen based on established clinical criteria and guidelines by the Panel on Clinical Practices for Treatment of HIV infection education about the medications including actions side effects special requirements setting up the medication schedule and follow-up regarding medication taking The usual RRB education includes information about risk reduction practices such as condom use sexual practices needle cleansing and needle sharing Depending on the agency the usual care may be formalized and administered by health care providers nurses social workers andor health educators
This innovative project is designed to promote adherence to both ART and RRB something that has not been described so far in the literature Adherence to ART promotes health and reduces infectiousness including transmission of HIV from mother to fetus Adherence to RRB reduces the spread of HIV Thus if effective the intervention will promote health of HIV women and reduce the spread of HIV
The primary purpose of this randomized controlled behavioral trial is to test the effect of a nurse led group motivational intervention for HIV women on adherence to ART and RRB The secondary purpose is to examine the mediator effect of 3 variables that have been shown to be important in behavior change self-efficacy outcome expectancy and personal goals The Motivational Group Usual Care MGUC intervention builds on the usual care provided at the agencies and has Motivational Interviewing MI as a central component It consists of 8 90 minute sessions 1 week apart led by a specially trained nurse to motivate women to adhere to both ART and RRB The intervention will be compared to an 8 session health promotion program HPPUC that is led by a nurse health educator These sessions will focus on nutrition exercise stress management and womens health issues These sessions will also be 90 minutes in length and meet weekly for 8 weeks Both groups will receive beauty and pampering incentives such as beauty makeovers skin care instruction and massages after several of the sessions as well as child care transportation tokens and monetary incentives of 10 for attendance at each of the first 4 groups and 15 for attendance at each of the last 4 groups Snacks appropriate for ART and immune status will be supplied to the MGUC group and fruits vegetables and other nutritious snacks will be provided to the HPPUC group Groups will be held at AID Atlanta the Infectious Disease Program of the Grady Health System and at the Infectious Disease Clinic of Emory Crawford Long
In order to be eligible to participate the women must be HIV over 18 years of age be on a new or different ART or have self-reported nonadherence to her current ART regimen speak and understand English and be mentally stable as determined by a screening assessment All participants will complete a baseline assessment and follow-up assessments immediately 3 6 and 9 months after the end of the group Participants will be paid 25 for each assessment We expect 300 women to be randomized and participate pregnant women will not be excluded
We hypothesize that the women who are randomized to the MGUC group will on the immediate 3 6 and 9 month follow-up assessments have higher mean adherence rates to ART report more frequent use of RRB have higher CD4 counts and lower mean viral loads than those randomized to the HPPUC group We also hypothesize that the effects of the intervention on adherence to ART and RRB will be brought about by higher mean levels of self-efficacy more positive expected outcomes and more specific and effective personal goals
As noted above MI forms the basis for the intervention MI is a client-focused method of counseling used to help clients deal with ambivalence about changing behavior MI principles include expressing empathy developing discrepancy rolling resistance and supporting self-efficacy It has been used primarily with individuals but some MI groups have been described with substance users Our application in a group format with HIV women is new and innovative
All participants will receive the usual care plus either the Health Promotion Program or the Motivational Interviewing Intervention How the usual care is administered varies by agency but in general for ART consists of prescription of new or different ART regimen based on established clinical criteria and guidelines by the Panel on Clinical Practices for Treatment of HIV infection education about the medications including actions side effects special requirements setting up the medication schedule and follow-up regarding medication taking The usual RRB education includes information about risk reduction practices such as condom use sexual practices needle cleansing and needle sharing Depending on the agency the usual care may be formalized and administered by health care providers nurses social workers andor health educators
This innovative project is designed to promote adherence to both ART and RRB something that has not been described so far in the literature Adherence to ART promotes health and reduces infectiousness including transmission of HIV from mother to fetus Adherence to RRB reduces the spread of HIV Thus if effective the intervention will promote health of HIV women and reduce the spread of HIV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01NR008094-01A1 | NIH | None | httpsreporternihgovquickSearch1R01NR008094-01A1 |